Pozen Migraine Combo “Not Approvable”; Company Seeks Meeting With FDA
This article was originally published in The Pink Sheet Daily
Executive Summary
Naproxen/metoclopramide fixed-dose combo did not meet efficacy endpoints in second study, FDA letter says. Agency also questions potential risk of tardive dyskinesia and carcinogenicity in denying approval of MT-100.
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Pozen MT-100 Migraine Combo Goes To Advisory Committee August 4
Tardive dyskinesia and cardiovascular issues are likely discussion topics for FDA’s Peripheral & Central Nervous System Drugs Advisory Committe. Treatment was to be reviewed by the committee in May but was postponed due to “scheduling conflicts.”
Pozen MT-100 Migraine Combo Goes To Advisory Committee August 4
Tardive dyskinesia and cardiovascular issues are likely discussion topics for FDA’s Peripheral & Central Nervous System Drugs Advisory Committe. Treatment was to be reviewed by the committee in May but was postponed due to “scheduling conflicts.”
Pozen Migraine Agent Advisory Cmte. Postponed; August Meeting Possible
Tardive dyskinesia risk with MT-100, the metoclopromide/naproxen combination product for migraine, continues to be the focus of a committee meeting, Pozen says. NDA filing for sumatriptan/naproxen migraine product Trexima is planned for the third quarter.